Class 2 Device Recall BD CAthena Safety IV Catheter

• Date Initiated by Firm: August 29, 2023
• Date Posted: October 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0025-2024
• Recall Event ID: 92970
• 510(K)Number: K220584
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
• Code Information: Lot # 2238464/ UDI-DI: (01)00382903868629
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy Systems Inc.; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: North American Regional Complaint Center; 1844-823-5433
• Manufacturer Reason for Recall: There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
• FDA Determined Cause: Process change control
• Action: On August 29, 2023, Becton Dickinson issued an "Urgent Medical Device Recall" notification via. FedEx. Becton Dickinson asked consignees to take the following actions: 1. Immediately review your inventory for Catalog Number 386862, Lot number 2238464. Destroy all unused product subject to the recall following your institution's process for destruction. 2. For indwelling catheters, no further action is needed. 3. If a defective product was used on a patient and the used needle was disposed of without the clinician suffering a needlestick injury, no further action is necessary to further protect the patient or the clinician. 4. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch, Phone: 1-800-FDA 1088 (1-800-332-1088), Mail: MedWatch, HF-2, FDA, 5600 Fisher.s Lane, Rockville, MD 20852-978
• Quantity in Commerce: 98,000 units
• Distribution: US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FOZ